[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517745":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":27,"locations":10,"responsibleParty":32,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":10,"studyType":48,"phases":10,"briefSummary":49,"conditions":50,"keywords":10,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Calcified Aortic Stenosis",null,"Patients with calcified aortic valve or aortic stenosis will be enrolled Stool, blood samples and aortic valve of operated patients will be retrieved to evaluate the composition of the gut microbiota and its metabolites A follow up is planned for patients with no intervention on the aortic valve to assess the evolution of the aortic stenosis and the change in the gut microbiota.",[13],"Other: No intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Control","Patients without calcified aortic valve will be enrolled Stool and blood samples will be retrieved to evaluate the composition of the gut microbiota and its metabolites No follow up is scheduled.",[13],[19],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":10},"No intervention",[9,15],[23],{"name":24,"affiliation":25,"role":26},"Caroline Nguyen, MD","Insel Gruppe AG","PRINCIPAL_INVESTIGATOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+41316325000","caroline.chong-nguyen@insel.ch",{"type":33,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100517745","involvement-of-the-gut-microbiota-in-calcified-aortic-stenosis-100517745",false,"NCT06021535","Involvement of the Gut Microbiota in Calcified Aortic Stenosis","Involvement of the Gut Microbiota and Its Metabolites in the Pathophysiology of Calcified Aortic Stenosis","Gut-CAS","Inclusion Criteria:\n\n* Group of patients with CAS:\n* Calcified aortic stenosis diagnosed on a cardiac ultrasound or CT not older than 3 months\n* Severe aortic stenosis: surgical indication based on symptoms and ultrasound data (high gradient aortic stenosis : Vmax\\> 4m\u002Fs, mean gradient \\> 40mmHg, area \\\u003C 1cm², low flow low-gradient CAS: left ventricular ejection fraction (LVEF) \\\u003C 40%, Vmax\\\u003C 4m\u002Fs, mean gradient \\\u003C 40mmHg, area \\\u003C 1cm², paradoxical low-gradient CAS: LVEF \\> 55%, Vmax\\\u003C 4m\u002Fs, mean gradient \\\u003C 40mmHg, area \\\u003C 1cm²)\n* Moderate CAS: 3m\u002Fs \\\u003CVmax\\\u003C 4m\u002Fs, 20mmHg \\\u003C mean gradient \\\u003C 40mmHg\n* Mild CAS: 2,6m\u002Fs \\\u003C Vmax \\\u003C 2.9m\u002Fs, mean gradient \\\u003C 20mmHg\n* Aortic sclerosis: calcified remodeling of the aortic valve visible on ultrasound or CT.\n\nControl group - free of CAS:\n\n\\- No calcified aortic stenosis verified on a cardiac ultrasound or CT not older than 3 months\n\nExclusion Criteria:\n\n* Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants\n* Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease\n* Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral insufficiency, cardiogenic shock).\n* AS of rheumatic origin, infective endocarditis.","ALL","18 Years","90 Years",{"count":46,"type":47},100,"ESTIMATED","OBSERVATIONAL","Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation. It is the most frequent cause of valve disease in the elderly. To date, no means of preventing the disease has been discovered, and the only treatment available is valve replacement during cardiac surgery, or percutaneous implantation of a valve prosthesis when the narrowing becomes severe and causes symptoms.\n\nThe intestinal flora or microbiota, the reservoir of all the microorganisms in the gut, is implicated in numerous diseases, particularly of the intestine. But to date, no study has established a link between CAS and microbiota. The intestinal microbiota acts through molecules produced by itself or the host and passing into the bloodstream. In the pathophysiology of CAS, the valve leaflets are breached and do not heal. These molecules can enter and have beneficial or deleterious effects, in particular promoting calcification of aortic valve cells.\n\nConcrete objectives:\n\nImprove understanding of calcific aortic stenosis in humans Study the composition of intestinal flora in patients with aortic stenosis and compare it with healthy subjects Study the molecules in the intestinal flora likely to be involved in the development of aortic stenosis in humans.",[51,52,53],"Aortic Stenosis","Gastrointestinal Microbiome","Metabolomics","NOT_YET_RECRUITING","2023-08-29",{"date":57,"type":58},"2023-09-01","ACTUAL",{"date":60,"type":47},"2024-01-01",{"date":62,"type":47},"2028-12-31",{"name":5,"class":6}]